Important safety label changes to cholesterol-lowering statin drugs (2023)

Facts about statins

  • A class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”)
  • Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin)
  • Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
Lovastatin Dose Limitations
References

Safety Announcement

[2-28-2012] The U.S. Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. These changes were made to provide the public with more information for the safe and effective use of statins and are based on FDA’s comprehensive review of the statin class of drugs (see Data Summary below). The changes include the following:

Infographic About Cholesterol and Statins

Monitoring Liver Enzymes
Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.

(Video) Statin Misinformation: Mayo Clinic Radio

Adverse Event Information
Information about the potential for generally non-serious and reversible cognitive side effects (memory loss, confusion, etc.) and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.

Drug Interactions
The lovastatin label has been extensively updated with new contraindications (situations when the drug should not be used) and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury (see Lovastatin Dose Limitations below).

Healthcare professionals should refer to the drug labels for the latest recommendations for prescribing statins (also see Additional Information for Healthcare Professionals below). Patients should contact their healthcare professional if they have any questions or concerns about statins.

Additional Information for Patients

  • The statin drug labels have been revised to provide patients with more information on the safe and effective use of statins. Patients should be aware of the following information:
    • There have been rare reports of serious liver problems in patients taking statins. Patients should notify their healthcare professional right away if they have the following symptoms: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; or yellowing of the skin or the whites of the eyes.
    • Memory loss and confusion have been reported with statin use. These reported events were generally not serious and went away once the drug was no longer being taken.
    • Increases in blood sugar levels have been reported with statin use.
    • Certain medicines should never be taken (are contraindicated) with lovastatin (Mevacor) (see Lovastatin Dose Limitations below).
  • Patients should contact their healthcare professional if they have any questions or concerns about statins.
  • Patients should report side effects from the use of statins to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

Additional Information for Healthcare Professionals

  • Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.
  • There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
  • Increases in glycosylated hemoglobin (HbA1c) and fasting serum glucose levels have been reported with statin use.
  • Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin (see Lovastatin Dose Limitations below).
  • Healthcare professionals should report adverse events involving statins to the FDA MedWatch program using the information in the "Contact FDA" box at the bottom of this page.

Data Summary

(Video) What to Avoid When Taking Statin Medications | How to Reduce Risk of Statin Side Effects

Removal of routine monitoring of liver enzymes from drug labels

FDA reviewed current monitoring guidelines, including the National Lipid Association’s Liver Expert Panel and Statin Safety Task Force recommendations.1, 2 The Liver Expert Panel stated that the available scientific evidence does not support the routine monitoring of liver biochemistries in asymptomatic patients receiving statins. The Panel made this recommendation because (1) irreversible liver damage resulting from statins is exceptionally rare and is likely idiosyncratic in nature, and (2) no data exist to show that routine periodic monitoring of liver biochemistries is effective in identifying the very rare individual who may develop significant liver injury from ongoing statin therapy. The Panel believed that routine periodic monitoring will instead identify patients with isolated increased aminotransferase levels, which could motivate physicians to alter or discontinue statin therapy, thereby placing patients at increased risk for cardiovascular events.1 The National Lipid Association’s Statin Task Force also stated that routine monitoring of liver function tests is not supported by the available evidence.2

FDA reviewed post-marketing data to evaluate the risk of clinically serious hepatotoxicity associated with statins. FDA had conducted several post-marketing reviews of statins and hepatotoxicity between years 2000 and 2009 by searching the Agency’s Adverse Event Reporting System (AERS) database. Those reviews consistently noted that reporting of statin-associated serious liver injury to the AERS database was extremely low (reporting rate of ≤2 per one million patient-years). FDA’s updated review focused on cases of severe liver injury, defined as a 4 (severe liver injury) or a 5 (death or liver transplant) using the Drug Induced Liver Injury Network (DILIN) liver injury severity scale, which were reported to AERS from marketing of each statin through 2009. Cases meeting those criteria were further assessed for causality. Seventy-five cases (27 cases with a severity score of 4, and 48 cases with a severity score of 5 (37 deaths and 11 liver transplants) were assessed for causality. Thirty of the 75 cases (14 deaths, 7 liver transplantations, and 9 severe liver injury) were assessed as possibly or probably associated with statin therapy. No cases were assessed as highly likely or definitely associated with statin therapy. FDA concluded that, despite a rising use of statins as a class since the late 1990s, there has not been a detectable increase in the annual rates of fatal or severe liver injury cases possibly or probably causally associated with statin use.

FDA also reviewed cases from the DILIN and Acute Liver Failure Study Group (ALFSG), organizations that have been submitting reports to FDA of drug-associated liver injury in their liver injury outcome studies. As of January 1, 2011, DILIN had submitted 25 reports of statin-associated liver injury to FDA, 12 of which gave hospitalization as an outcome. A 2010 article from ALFSG included 133 prospectively identified cases of idiopathic drug-induced liver injury resulting in acute liver failure.3 Of these 133 patients, 15 were taking statins, and in six of these 15 individuals a statin was identified as the only potential drug to cause drug-induced liver injury.

Based on all available data, FDA has determined that all currently marketed statins appear to be associated with a very low risk of serious liver injury and that routine periodic monitoring of serum alanine aminotransferase (ALT) does not appear to detect or prevent serious liver injury in association with statins.

Cognitive adverse events

(Video) Getting to you LDL-C Goal and Staying There: Why is it So Important?

FDA reviewed the AERS database, the published medical literature (case reports and observational studies),4-13 and randomized clinical trials to evaluate the effect of statins on cognition.14-17

The post-marketing adverse event reports generally described individuals over the age of 50 years who experienced notable, but ill-defined memory loss or impairment that was reversible upon discontinuation of statin therapy. Time to onset of the event was highly variable, ranging from one day to years after statin exposure. The cases did not appear to be associated with fixed or progressive dementia, such as Alzheimer’s disease. The review did not reveal an association between the adverse event and the specific statin, the age of the individual, the statin dose, or concomitant medication use.

Data from the observational studies and clinical trials did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline.

Increases in glycosylated hemoglobin (HbA1c) and fasting plasma glucose

FDA’s review of the results from the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) reported a 27% increase in investigator-reported diabetes mellitus in rosuvastatin-treated patients compared to placebo-treated patients. High-dose atorvastatin had also been associated with worsening glycemic control in the Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy.18

FDA also reviewed the published medical literature.19-26 A meta-analysis by Sattar et al.,19 which included 13 statin trials with 91,140 participants, reported that statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1.09; 95% confidence interval [CI] 1.02-1.17), with little heterogeneity (I2=11%) between trials. A meta-analysis by Rajpathak et al.,20 which included 6 statin trials with 57,593 participants, also reported a small increase in diabetes risk (relative risk [RR] 1.13; 95% CI 1.03-1.23), with no evidence of heterogeneity across trials. A recent study by Culver et al.,26 using data from the Women’s Health Initiative, reported that statin use conveys an increased risk of new-onset diabetes in postmenopausal women, and noted that the effect appears to be a medication class effect, unrelated to potency or to individual statin.

(Video) Should you take a statin for cholesterol control?

Based on clinical trial meta-analyses and epidemiological data from the published literature, information concerning an effect of statins on incident diabetes and increases in HbA1c and/or fasting plasma glucose was added to statin labels.

Lovastatin drug-drug interactions

Information regarding drug-drug interactions and contraindications and dose limitations has been added to the lovastatin label. Subsequent to the June 2011 label revisions to the simvastatin-containing products, which were based largely on the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial,27 a review of drug-drug interactions with lovastatin was conducted because the physicochemical and pharmacokinetic properties of lovastatin are comparable to those of simvastatin.

Lovastatin is a sensitive in vivo cytochrome P450 3A4 (CYP3A4) substrate. Strong CYP3A4 inhibitors are predicted to significantly increase lovastatin exposure. A literature review indicates that itraconazole, a strong CYP3A4 inhibitor, increases lovastatin exposure up to 20-fold and the drug interaction appears to result in rhabdomyolysis.28 The effect of itraconazole on lovastatin exposure can therefore be extrapolated to other strong CYP3A4 inhibitors, including ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, human immunodeficiency virus (HIV) protease inhibitors, boceprevir, telaprevir, and nefazodone.

Lovastatin Dose Limitations

Previous lovastatin labelNew lovastatin label

Avoid lovastatin with:

  • Itraconazole
  • Ketoconazole
  • Erythromycin
  • Clarithromycin
  • Telithromycin
  • HIV protease inhibitors
  • Nefazodone

Contraindicated with lovastatin:

  • Itraconazole
  • Ketoconazole
  • Posaconazole
  • Erythromycin
  • Clarithromycin
  • Telithromycin
  • HIV protease inhibitors
  • Boceprevir
  • Telaprevir
  • Nefazodone

Do not exceed 20 mg lovastatin daily with:

  • Gemfibrozil
  • Other fibrates
  • Lipid-lowering doses (≥1 g/day) of niacin
  • Cyclosporine
  • Danazol

Avoid with lovastatin:

  • Cyclosporine
  • Gemfibrozil

Do not exceed 20 mg lovastatin daily with:

  • Danazol
  • Diltiazem
  • Verapamil

Do not exceed 40 mg lovastatin daily with:

  • Amiodarone
  • Verapamil

Do not exceed 40 mg lovastatin daily with:

  • Amiodarone

Avoid large quantities of grapefruit juice (>1 quart daily)

Avoid large quantities of grapefruit juice (>1 quart daily)

References

(Video) Reduce LDL Cholesterol Naturally (IN JUST 10 DAYS)!!!

  1. Cohen DE, Anania FA, Chalasani N; for the National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006;97(8A):77C-81C.
  2. McKenney JM, Davidson MH, Jacobson TA, Guyton JR. Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force. Am J Cardiol. 2006;97(8A):89C-94C.
  3. Reuben A, Koch DG, Lee WM; for the Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology. 2010;52(6):2065-2076.
  4. Orsi A, Sherman O, Woldeselassie Z. Simvastatin-associated memory loss. Pharmacotherapy. 2001;21:767-9.
  5. Wagstaff LR, Mitton MW, Arvik BM, Doraiswamy PM. Statin-associated memory loss: analysis of 60 case reports and review of the literature. Pharmacotherapy. 2003;23:871-80.
  6. Evans MA, Golomb BA. Statin-associated adverse cognitive effects: survey results from 171 patients. Pharmacotherapy. 2009;29:800-811.
  7. Parker BA, Polk DM, Rabdiya V, et al. Changes in memory function and neuronal activation associated with atorvastatin therapy. Pharmacotherapy. 2010;30(6):236e-240e.
  8. Zamrini E, McGwin G, Roseman JM. Association between statin use and Alzheimer's disease. Neuroepidemiology. 2004;23:94-98.
  9. Zandi PP, Sparks DL, Khachaturian AS, et al. Do statins reduce risk of incident dementia and Alzheimer disease? The Cache County Study. Arch Gen Psychiatry. 2005;62:217-224.
  10. Zhou B, Teramukai S, Fukushima M. Prevention and treatment of dementia or Alzheimer's disease by statins: a meta-analysis. Dement Geriatr Cogn Disord. 2007;23:194-201.
  11. Beydoun MA, Beason-Held LL, Kitner-Triolo MH, et al. Statins and serum cholesterol's associations with incident dementia and mild cognitive impairment. J Epidemiol Community Health. 2011;65:949-957.
  12. Bettermann K, Arnold AM, Williamson J, et al. Statins, risk of dementia, and cognitive function: secondary analysis of the Ginkgo Evaluation of Memory Study. J Stroke Cerebrovasc Dis. http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2010.11.002. Accessed January 31, 2012.
  13. Benito-León J, Louis ED, Vega S, Bermejo-Pareja F. Statins and cognitive functioning in the elderly: a population-based study. J Alzheimers Dis. 2010;21:95-102.
  14. Muldoon MF, Barger SD, Ryan CM, et al. Effects of lovastatin on cognitive function and psychological well-being. Am J Med. 2000;108:538-546.
  15. Muldoon MF, Ryan CM, Sereika SM, Flory JD, Manuck SB. Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults. Am J Med. 2004;117:823-829.
  16. Trompet S, van Vliet P, de Craen AJ, et al. Pravastatin and cognitive function in the elderly. Results of the PROSPER study. J Neurol. 2010;257:85-90.
  17. Feldman HH, Doody RS, Kivipelto M, et al. Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe. Neurology. 2010;74:956-964.
  18. Sabatine MS, Wiviott SD, Morrow DA, McCabe CH, Cannon CP. High-dose atorvastatin associated with worse glycemic control: a PROVE-IT TIMI 22 substudy. Circulation. 2004;110(Suppl I):S834.
  19. Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375(9716):735-742.
  20. Rajpathak SN, Kumbhani DJ, Crandall J, Barzilai N, Alderman M, Ridker PM. Statin therapy and risk of developing type 2 diabetes: a meta-analysis. Diabetes Care. 2009;32(10):1924-1929.
  21. Sukhija R, Prayaga S, Marashdeh M, et al. Effect of statins on fasting plasma glucose in diabetic and nondiabetic patients. J Investig Med. 2009;57:495-499.
  22. Koh KK, Quon MJ, Han SH, Lee Y, Kim SJ, Shin EK. Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol. 2010;55:1209-1216.
  23. Thongtang N, Ai M, Otokozawa S, et al. Effects of maximal atorvastatin and rosuvastatin treatment on markers of glucose homeostasis and inflammation. Am J Cardiol. 2011;107:387-392.
  24. Kostapanos MS, Liamis GL, Milionis HJ, Elisaf MS. Do statins beneficially or adversely affect glucose homeostasis? Curr Vasc Pharmacol. 2010;8:612-631.
  25. Mills EJ, Wu P, Chong G, et al. Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials. QJM. 2011;104:109-124.
  26. Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012;172(2):144-152.
  27. Armitage J, Bowman L, Wallendszus K; for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group. , et al. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Lancet. 2010;376:1658-1669.
  28. Lees RS, Lees AM. Rhabdomyolysis from the coadministration of lovastatin and the antifungal agent itraconazole. N Engl J Med. 1995;333:664-555.

Related Information

  • Cholesterol-lowering drugs get labeling changes
  • FDA announces safety changes in labeling for some cholesterol-lowering drugs
  • FDA Expands Advice on Statin Risks
  • Statins
  • FDA Drug Safety Podcast for Healthcare Professionals: Important safety label changes to cholesterol-lowering statin drugs
  • Statinas: Cambios importantes en la etiqueta de seguridad de los medicamentos para reducir el colesterol conocidos como estatinas

ResourcesForYou

  • FDA announces safety changes in labeling for some cholesterol-lowering drugs
  • Infographic about Cholesterol and Statins

FAQs

What's an important precaution when taking statin drugs? ›

Statins should be taken with caution if you're at an increased risk of developing a rare side effect called myopathy, which is where the tissues of your muscles become damaged and painful. Severe myopathy (rhabdomyolysis) can lead to kidney damage.

What is the controversy surrounding statins? ›

A controversial new study found that high cholesterol does not shorten life span and that statins are essentially a “waste of time,” according to one of the researchers. Previous studies have linked statins with an increased risk of diabetes.

Do statins have a black box warning? ›

Background: In 2012, the U.S. Food and Drug Administration (FDA) mandated black box warnings for all statin drugs for possible adverse effects on cognitive performance including memory loss, amnesia, and confusion.

What is an important recommendation regarding the use of a statin? ›

Recommendation Summary

The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (i.e. dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year risk of a cardiovascular event of 10% or greater.

What are the risk factors of taking statins? ›

inflammation of the liver (hepatitis), which can cause flu-like symptoms. inflammation of the pancreas (pancreatitis), which can cause stomach pain. skin problems, such as acne or an itchy red rash. sexual problems, such as loss of libido (reduced sex drive) or erectile dysfunction.

What is the safest statin to take? ›

According to a research review people who take simvastatin (Zocor) or pravastatin (Pravachol) may experience fewer side effects.

Why do cardiologists push statins? ›

Because many factors are involved, your cholesterol numbers may be considered normal and yet you may still be found to be at an elevated risk for heart problems. As a result, statin medications are now used to lower the risk of heart disease and heart events in most anyone found to be at high risk.

How can I lower my cholesterol without taking statins? ›

A few changes in your diet can reduce cholesterol and improve your heart health:
  1. Reduce saturated fats. Saturated fats, found primarily in red meat and full-fat dairy products, raise your total cholesterol. ...
  2. Eliminate trans fats. ...
  3. Eat foods rich in omega-3 fatty acids. ...
  4. Increase soluble fiber. ...
  5. Add whey protein.

Is there a recall on atorvastatin 2022? ›

According to the April 6, 2022, US Food and Drug Administration (FDA) Enforcement Report, testing yielded “out-of-specification results for [a] related substance.” The recall affects atorvastatin calcium tablets, 80 mg, 90-count bottles (NDC 55111-124-90), from lots T000707, T000756, T000758, and T000759 (Exp.

Are statins carcinogenic? ›

Studies have yet to prove that statins may actually cause cancer. Many of these studies found a strong association between long term statin therapy and higher rates of cancer. Those who need to take statin drugs may have other risk factors for cancer, or the drug may increase the risk.

Which statin is safest for liver? ›

Based on records from the Swedish national registry, their results demonstrate that individuals who took a lipophilic statin (in this case atorvastatin or simvastatin) were at a significantly lower risk of developing liver cancer than those who were not taking a statin (3.3% versus 8.1%).

What is the best statin for the elderly? ›

Atorvastatin or fluvastatin are usually recommended because there is no need to adjust the dose according to the glomerular filtration rate [28]. In patients without diagnosed atherosclerotic cardiovascular disease, it is indicated a moderate dose of statin, such as atorvastatin 20 mg daily [28].

Why do statins have to be taken at night? ›

So, why do people take statins at night? Many statins work more effectively when they are taken at night. This is because the enzyme which makes the cholesterol is more active at night. Also, the half-life, or the amount of time it takes for half the dose to leave your body, of some statins is short.

What is the most serious side effect of atorvastatin? ›

Serious side effects

you get unexplained muscle pain, tenderness, weakness or cramps – these can be signs of muscle breakdown and kidney damage.

Why was Crestor taken off the market? ›

Bayer withdrew cerivastatin in August, 2001, after the occurrence of unexpected cases of fatal rhabdomyolysis. The 80 mg dose of rosuvastatin was withdrawn by AstraZeneca because of safety concerns. Some critics are even anxious about the 40 mg dose.

What are statin contraindications? ›

Statins are contraindicated for use by patients with active hepatic disease or unexplained persistent elevations in aminotransferase levels. Statins are contraindicated during pregnancy and while breastfeeding because of the effects on the cholesterol pathway.

Can statins harm your heart? ›

One alarming study of 28,000 patients found that 3 in 10 stopped taking their statins because they presumed the aches and pains they were experiencing were due to the drug. The result: 8.5% suffered a heart attack or stroke within just four years, compared to 7.6% who continued taking the drugs13.

Who Cannot tolerate statins? ›

Studies show that about 5 percent to 10 percent of people are unable to tolerate statins, largely because of muscle aches and related side effects, including potential muscle damage.

Is there a natural substitute for statins? ›

Some people do not tolerate statins or may want to try natural remedies to treat their high cholesterol. Statin alternatives include some prescription medications like ezetimibe and fibric acids. Natural remedies that some people use to help treat high cholesterol include omega-3 fatty acids and red yeast rice extract.

What should a 70 year old cholesterol be? ›

After having their cholesterol tested, seniors should be given a number between 190 and 260. Healthy seniors should keep their total cholesterol below 200 and their LDL cholesterol around 100. If your elderly loved one's LDL cholesterol level is above 160, he or she must start making sweeping lifestyle changes.

What is the first drug of choice for cholesterol? ›

Statins. What they are: These are usually the first type of drug that doctors prescribe to lower LDL. They also lower triglycerides, which are another type of blood fat, and mildly raise your "good" (HDL) cholesterol.

What is the best cholesterol medicine that is not a statin? ›

Ezetimibe (Zetia)

It's one of the few non-statin drugs that can lower LDL cholesterol levels even more when added on top of statin. And, it's the only drug that, when combined with a statin, further lowers the risk of cardiovascular disease. It comes in tablet form and needs to be taken only once a day.

Can you get off statins Once you start? ›

If you're taking a statin medication to lower your cholesterol, you will need to keep taking your prescription, or your cholesterol will likely go back up. Stopping your statin can put you at risk of having heart disease and other preventable health problems like stroke and heart attack from high cholesterol.

Do statins harden your arteries? ›

Statins don't just lower cholesterol levels but also reduce the risk of fatty plaques breaking off from walls of your arteries, reducing the risk of heart attack and stroke.

Do statins cause strokes? ›

A study of more than 135,000 people at risk for a heart attack or stroke found that those who took statins had a 25% lower risk of having a heart attack or stroke compared to those who did not take statins. Statins are among the safest and most studied medications.

What is the best drink to lower cholesterol? ›

Some of the best drinks for cholesterol management include green tea, pomegranate juice, citrus juice, soy milk, plant-based smoothies, and red wine.

What is the best natural thing to take to lower cholesterol? ›

The soluble fiber in foods like oat bran, barley, psyllium seeds, flaxseed meal, apples, citrus fruits, lentils, and beans are particularly effective at lowering total and LDL cholesterol. Nuts: Ones like almonds, walnuts, pecans, and pistachios can reduce cholesterol.

What foods cancel out cholesterol? ›

Oatmeal, oat bran and high-fiber foods

Oatmeal contains soluble fiber, which reduces your low-density lipoprotein (LDL) cholesterol, the "bad" cholesterol. Soluble fiber is also found in such foods as kidney beans, Brussels sprouts, apples and pears.

Why should over 70s not take atorvastatin? ›

Compared to younger adults, older adults are more likely to suffer serious side effects from using statins. Statins can cause muscle problems, such as aches, pains, or weakness. Rarely, there can be a severe form of muscle breakdown.

Which statin was removed from the market? ›

The maker of cerivastatin, a popular cholesterol-lowering drug used by about 700,000 Americans, voluntarily pulled the medicine off the market yesterday because of numerous deaths associated with its use.

What is the best alternative to atorvastatin? ›

  • Other alternatives to atorvastatin.
  • Other HMG CoA Reductase Inhibitors (statins) such as: Crestor (rosuvastatin), Zocor (simvastatin), Pravachol (pravastatin), or Mevachor (lovastatin)
  • Colestid (colestipol)
  • Tricor (fenofibrate)
  • Zetia (ezetimibe)
  • WelChol (colesevelam)
5 May 2022

Is statin worth the risk? ›

And so, in general, although there are some potential side effects long-term for statins, in most cases, if your doctor has identified you as having high cholesterol and needing a statin, the risks greatly outweigh, or sorry, the benefits greatly outweigh the risks.

Can statins cause dementia? ›

A 2021 study looked at data of more than 18,000 adults over 65 years old who were taking statins: Main finding: There was no significant link between statins and dementia — or statins and any cognitive impairment.

Does statin cause Alzheimer's? ›

Statins have been convincingly shown to reduce the risk of atherosclerotic heart disease and ischemic stroke. In addition to their cardiovascular benefits, statins appear modestly to reduce the risk for developing Alzheimer's dementia.

What are 3 contraindications of statins? ›

having a history of liver disease. regularly drinking large quantities of alcohol. having a history of muscle-related side effects when taking a statin or fibrate (another type of medicine for high cholesterol) having a family history of myopathy or rhabdomyolysis.

How common is liver damage from statins? ›

The risk of hepatic injury caused by statins is estimated to be about 1 percent, similar to that of patients taking a placebo. Patients with transaminase levels no more than three times the upper limit of normal can continue taking statins; often the elevations will resolve spontaneously.

Is liver damage from statins reversible? ›

Fortunately, severe liver injury is uncommon with statin use and is generally reversible without any intervention other than offending statin cessation.

Should a 70 year old woman take statins? ›

Statins are used to prevent heart attacks, strokes, and other life-threatening events associated with heart disease. Because strong evidence from clinical studies show the benefits of statins for adults up to age 75, doctors often prescribe them.

Should all 70 year olds take statins? ›

Statin drugs have been shown to reduce the risk of cardiovascular disease (CVD) in young and middle-aged adults. With older adults (those 75 and over), the benefits are less clear. But a recent study published in the European Heart Journal suggests that there is in fact a benefit to statin use in this older population.

What are the new guidelines for statins? ›

From the 2021 ESC guidelines, adults 40 to 49 years are eligible for statins if their 10-risk ASCVD risk is 7.5% or greater (class I recommendation). For those aged 50 to 69 years, statins are a class I recommendation if they have a 10-year risk of 10.0% or greater.

What foods to avoid while taking statins? ›

Grapefruit juice is the only food or drink that has a direct interaction with statins. Statins do not directly interact with any food but people taking statins should moderate their intake of saturated fats to help lower their LDL cholesterol and overall risk of cardiovascular disease.

Do statins lower BP? ›

“We found that statins lower both systolic and diastolic blood pressure, and that the effect extends to patients with pre-hypertension, those with normal blood pressure and persons not on blood-pressure lowering medications,” said Golomb.

Can you take blood pressure and cholesterol medicine at the same time? ›

Combining medication that lowers blood pressure with medication that lowers cholesterol reduced first-time strokes by 44 percent. For those with very high blood pressure — readings 143.5 mm Hg or higher — taking two types of blood pressure-lowering drugs together every day reduced stroke by 42 percent.

What is the safest statin to take with the least side effects? ›

According to a research review people who take simvastatin (Zocor) or pravastatin (Pravachol) may experience fewer side effects.

What are the two most common adverse effects of statins? ›

What are statin side effects?
  • Muscle pain and damage. One of the most common complaints of people taking statins is muscle pain. ...
  • Liver damage. Occasionally, statin use could cause an increase in the level of enzymes that signal liver inflammation. ...
  • Increased blood sugar or type 2 diabetes. ...
  • Neurological side effects.

What is the downside of atorvastatin? ›

Cons. Statins such as atorvastatin (Lipitor) can cause digestive problems, blood sugar problems, muscle aches and stiffness, muscle injury, kidney damage, or liver damage. Some people need to stop taking this medicine if these problems occur.

What are 3 contraindications of statins? ›

Statins are contraindicated for use by patients with active hepatic disease or unexplained persistent elevations in aminotransferase levels. Statins are contraindicated during pregnancy and while breastfeeding because of the effects on the cholesterol pathway.

What precautions should be taken for cholesterol? ›

Prevention
  • Eat a low-salt diet that emphasizes fruits, vegetables and whole grains.
  • Limit the amount of animal fats and use good fats in moderation.
  • Lose extra pounds and maintain a healthy weight.
  • Quit smoking.
  • Exercise on most days of the week for at least 30 minutes.
  • Drink alcohol in moderation, if at all.
  • Manage stress.
20 Jul 2021

What should be monitored while taking atorvastatin? ›

Patients starting atorvastatin should have liver function tests and a lipid panel performed at baseline, with a repeat lipid panel after six weeks of therapy. Liver function tests should be repeated as clinically indicated. Once the patient is stable, lipids can be checked every 6 to 12 months.

What vitamins should not be taken with statins? ›

Related Reviews (5)
  • Cholesterol-Lowering Supplements (Sterols/Stanols and Policosanol)
  • CoQ10 and Ubiquinol Supplements.
  • Fish Oil /Omega-3 Fatty Acid Supplements.
  • Red Yeast Rice Supplements.
  • St. John's Wort Supplements.

When should you take statins after age 70? ›

Adults age 75 and older may not need statins.

Their doctors usually prescribe statins to prevent heart disease. But for older people, there is no clear evidence that high cholesterol leads to heart disease or death.

Why do statins have to be taken at night? ›

So, why do people take statins at night? Many statins work more effectively when they are taken at night. This is because the enzyme which makes the cholesterol is more active at night. Also, the half-life, or the amount of time it takes for half the dose to leave your body, of some statins is short.

Why are statins not recommended in the elderly? ›

Statins should be prescribed with caution in elderly individuals, who may present more frequent side effects of the treatment than younger people, because of the multiple associated comorbidities and drug interactions.

What is the number one thing to lower cholesterol? ›

Reduce saturated fats.

Saturated fats, found primarily in red meat and full-fat dairy products, raise your total cholesterol. Decreasing your consumption of saturated fats can reduce your low-density lipoprotein (LDL) cholesterol — the "bad" cholesterol.

What is the best drink to lower cholesterol? ›

Some of the best drinks for cholesterol management include green tea, pomegranate juice, citrus juice, soy milk, plant-based smoothies, and red wine.

Do nuts raise cholesterol? ›

Almonds and other tree nuts can improve blood cholesterol. A recent study concluded that a diet supplemented with walnuts can lower the risk of heart complications in people with history of a heart attack. All nuts are high in calories, so a handful added to a salad or eaten as a snack will do.

What is the most serious side effect of atorvastatin? ›

Serious side effects

you get unexplained muscle pain, tenderness, weakness or cramps – these can be signs of muscle breakdown and kidney damage.

What test should be monitored in patients taking a statin? ›

Your doctor will carry out a blood test to measure a substance in your blood called creatine kinase (CK), which is released into the blood when your muscles are inflamed or damaged. If the level of CK in your blood is more than 5 times the normal level, your doctor may advise you to stop taking the statin.

What are the common contraindications of atorvastatin? ›

Statins should be used with caution in patients at increased risk of muscle toxicity, including those with a personal or family history of muscular disorders, previous history of muscular toxicity, a high alcohol intake, renal impairment or hypothyroidism.

Is it OK to take vitamin D with statins? ›

Vitamin D supplement may have moderate or no effect on the dosage requirement or side effects of pravastatin, rosuvastatin and pitavastatin. Since vitamin D has mild HMG-CoA reductase activity, it will work synergistically with all statins.

Can vitamin D cause high cholesterol? ›

Higher vitamin D levels appear to be associated with higher total cholesterol levels and higher HDL cholesterol levels, according to a new study presented at the American College of Cardiology's (ACC) 65th Annual Scientific Sessions.

Can I take magnesium instead of statins? ›

While statins can raise liver enzymes and cause myopathy, a muscle disease resulting in muscular weakness, and cause other side effects, magnesium can protect against myopathy and only has mild gastrointestinal side effects for some.

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